Discovery of novel biomarkers in peripheral arterial disease/metabolic syndrome
- Conditions
- Type 2 diabetes and peripheral arterial diseaseNutritional, Metabolic, Endocrine
- Registration Number
- ISRCTN46806801
- Lead Sponsor
- niversity of Dundee (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
For Phase 1 study subjects with PAD and type 2 diabetes will be included. PAD will be defined as patients with classical symptoms of intermittent claudication plus an Ankle brachial Blood Pressure Index (ABPI) of <0.9, the accepted cut off level for such a diagnosis.
For Phase 2 study patients with short distance claudication (<200 yards) will be selected for the walking study, as their walking distances are more reproducible (i.e. using the standardized Gardner walking treadmill protocol no more than 25% variation from 2 consecutive treadmill tests performed at least a week apart during the screening period). Patients for this second study will be type 2 diabetic patients not receiving insulin.
1. Contraindication to thiazolidinedione group of drugs
2. Subjects taking sulphonylureas
3. Subjects with cardiovascular disease event within last three months (such as Myocardial Infarction [MI], unstable angina and stroke)
4. For Phase 2 study, subjects having more than 25% variation from 2 consecutive treadmill tests performed at least a week apart
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Development of new biomarkers
- Secondary Outcome Measures
Name Time Method Correlate clinical parameters (e.g. walking distances) in patients with PAD and type 2 diabetes treated with various standard of care medicines to genes and protein profiling in muscle biopsies.